The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Bilirubin Special And Roche/hitachi Bilrubin Total, Models 20737496 322, 03261638 190, And 11822713 226.
| Device ID | K063543 |
| 510k Number | K063543 |
| Device Name: | COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50410 Indianapolis, IN 46250 -0416 |
| Contact | Corina Harper |
| Correspondent | Corina Harper ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50410 Indianapolis, IN 46250 -0416 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-24 |
| Decision Date | 2006-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630991266 | K063543 | 000 |
| 04015630913206 | K063543 | 000 |